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Food Importers Must Ensure Food Meets U.S. Safety Standards Under FDA’s Food Supplier Verification Program

Requirements take effect this week under the FDA’s new Food Safety Verification Program (FSVP), which makes retailers and other businesses that import food into the United States responsible for verifying that the food has been produced in a manner that meets applicable U.S. safety standards.

FSVP is one of the seven foundational rules of the FDA’s Food Safety Modernization Act (FSMA), the most sweeping reform of our food safety laws in more than 70 years. It aims to ensure the U.S. food supply is safe by shifting the focus from responding to contamination to preventing it.

A central tenet of the FSVP is that the same preventive food safety standards should apply to all food consumed in the U.S., regardless of where the food is produced. The FSVP therefore requires that importers have a program in place to verify that their foreign suppliers are producing food in a manner that

FDA Announces Waivers to Sanitary Transportation Rule

Today, FDA announced that it has issued the first three waivers under the Sanitary Transportation of Human and Animal Food Rule, one of the many rules designed to implement the Food Safety Modernization Act. These waivers are for the following entities:

•Businesses holding valid permits that are inspected under the National Conference on Interstate Milk Shipments’ Grade “A” Milk Safety Program, only when transporting Grade “A” milk and milk products.

•Food establishments authorized by the regulatory authority to operate when engaged as receivers, or as shippers and carriers in operations in which food is delivered directly to consumers, or to other locations the establishments or affiliates operate that serve or sell food directly to consumers. (Examples include restaurants, supermarkets and home grocery delivery services.)

•Businesses transporting molluscan shellfish (such as oysters, clams, mussels or scallops) that are certified and inspected under the requirements established by the Interstate Shellfish Sanitation Conference’s

What do FDA’s Preventive Controls Rules Actually Mean?

St. Louis Partner Brandon Neuschafer authored an article Nov. 10 in Refrigerated & Frozen Foods magazine concerning the FDA’s Preventive Controls Rules. Released on Sept. 10, the rules aim to shift the focus of U.S. food safety away from incident response and toward prevention. “FDA expects that many large facilities are already doing a vast majority of what is now being required,” Neuschafer wrote. “Those facilities may still need to develop additional documentation or tweak procedures. Interesting and complicated issues swirl around companies who are not themselves food facilities, but are technology and equipment providers to such facilities.” Click here to read his full article.

FSMA Final Rule on Preventive Controls for Human & Animal Food

September 25, 2015

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On September 17, 2015, the FDA announced two new final rules for the Food Safety Modernization Act (“FSMA”) (Pub. L. 111-353). The two new final rules are: (1) Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food and (2) Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Animal Food.

Covered facilities, which exclude farms, must create and implement a food safety systems that includes:

  • Hazard analysis: identification of known or reasonably foreseeable biological, chemical, and physical hazards
  • Preventive controls: measures that assure identified hazards can be minimized or prevented
  • Monitoring, verification, and corrective action plans for use of preventive controls; additionally, each animal food facility with a preventive control in place must develop a recall plan

For animal food facilities, Current Good Manufacturing Practices (“cGMP”) are being established for the first time. The animal food rule contains FDA’s baseline

FDA Proposes Draft Guidance on Mandatory Recall Authority

One key element of the 2011 Food Safety Modernization Act was the Act’s grant to FDA of powers to force a product recall.  Prior to FSMA, FDA had no such authority, and was required to use other authorities to “lean” on companies to conduct a recall.  Now, FDA may force a recall where it finds that there is a reasonable probability that food is adulterated or misbranded and the use of or exposure to the food will cause serious adverse health consequences or death to humans or animals.  In addition to satisfying this fairly substantial threshold, the responsible party must refuse to voluntarily conduct a recall.  The result is that FDA has initiated its mandatory recall authority only a couple of times, notably with respect to Kasel Associates Industries, Inc.’s pet treats and dietary supplements manufactured by USPLabs.

FDA recently issued draft nonbinding guidance regarding its mandatory recall authority.  The draft

It’s Time to Renew Your Food Facility Registration!

Beginning on October 1, 2014, food facilities required to be registered with the FDA must renew their food facility registrations.  The FDA currently requires registration for all domestic and foreign food facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States.  This food facility registration must be renewed every two years, and the current registration period lasts until December 31, 2014.  FDA has published a number of guidance documents to assist with the food facility registration requirements, including a Q&A document and a Small Business Compliance Guide.  More information on registration procedures can be found on FDA’s website.

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